• Audits (internal & vendor)

  • 21 CFR part 11

  • CAPA

  • CRO/CMO oversight

  • Change Control

  • Deviations

  • Disaster Recovery

  • Documentation

  • Quality Manual

  • Training

  • Validation (CSV, GAMP, Method, Process)

Solving the compliance puzzle
Solving the compliance puzzle

Team Approach
Team Approach

Business Growth
Business Growth

by planting the seeds of quality

Solving the compliance puzzle
Solving the compliance puzzle


FDA inspections are typically unannounced.


You MUST grant them access during normal business hours.


Are you ready for the FDA tomorrow morning?

Oversight Plans



  • Clinical

  • CMO

  • Outsourced services


Critical as the sponsor when you have outsourced functions.


Can you prove you are meeting your

Sponsor obligations?



QC Services



  • Environmental Monitoring

  • Final Release

  • Receipt Inspection

  • Method Development /Qualification 

  • Out of Specification (OOS)

  • Scale-up & Tech Transfer

IT Configurations



  • Front end and back end

  • Network security

  • Infrastructure qualification

  • GXP computerized systems

  • Lifecycle

  • VPN for employee remote access


IT stability increases uptime, allowing employees greater flexibility in performing their duties. 


The results are increased job satisfaction!